| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN13456221 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | AIM HIGH |
| Public title | A Randomised Study of Observation versus Adjuvant Low Dose Extended Duration Interferon Alpha-2a in High Risk Resected Malignant Melanoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Skin cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients with histologically proven malignant melanoma and high risk of recurrent metastatic disease will be eligible for the present study. This will include patients with either:
a. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at initial presentation
b. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at subsequent presentation
c. Non-nodal superficial regional recurrence (local or in-transit disease)
d. Primary tumours 4 mm or more Breslow thickness without any other detectable focus of metastasis
2. Fit to receive interferon
3. Wound healed following surgery
4. Clinically disease-free
5. No history of other malignant disease, except previously cured early carcinoma of the cervix or skin
6. No previous biological therapy
7. Not on systemic steroids or other immunosuppressive therapy
8. Not pregnant, lactating or intending pregnancy during treatment
9. Less than 12 weeks since resection |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 22/12/2000 |
| Status of trial | Completed |
| Target number of participants | 674 |
| Interventions | Patients are randomised to one of two treatment arms:
1. Arm A: Interferon alpha-2a 3MU three times per week until recurrence, or for 2 years.
2. Arm B: No further treatment. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | 2004 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14665609 |
| Sources of funding | Roche Products Ltd |
| Sponsor name | Roche Products Limited (UK) |
| Sponsor details | P.O. Box 8
Welwyn Garden City, Hertfordshire
United Kingdom
AL7 3AY |
| Sponsor website | http://www.roche.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN13456221 |
| Date last extracted from ISRCTN register | 17/04/2008 |
